ALLERTINE

What it is

ALLERTINE is available as tablets containing 20 mg of bilastine, with two formulations: standard tablets and orally disintegrating tablets (ALLERTINE MELTLETS) . Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H1 receptor antagonist affinity and no affinity for muscarinic receptors .

Approved indications

— Symptomatic treatment of allergic rhinoconjunctivitis (seasonal allergic rhinitis and perennial allergic rhinitis) in adults and adolescents aged 12 to 17 years — Symptomatic treatment of urticaria in adults and adolescents aged 12 to 17 years

Dosing overview

ALLERTINE is taken as one tablet daily as required for symptom control according to allergen exposure, symptom severity and expected course of symptoms in adults and adolescents aged 12 to 17 years . ALLERTINE tablets should be swallowed whole with a glass of water at least 1 hour before or 2 hours after food or fruit juice intake, while ALLERTINE MELTLETS should be placed in the mouth where it disperses rapidly in saliva and can be easily swallowed, also taken at least 1 hour before or 2 hours after food or fruit juice intake . No dosage adjustment is required in renal or hepatic impairment or in elderly patients .

Key safety warnings

In patients with moderate or severe renal impairment, co-administration of ALLERTINE with P-glycoprotein inhibitors such as cyclosporine or diltiazem should be approached with caution as elevated bilastine plasma levels and higher incidence of adverse reactions such as dizziness, headache and nausea may occur . ALLERTINE is subject to additional monitoring in Australia to allow quick identification of new safety information .

Contraindications

ALLERTINE is contraindicated in patients with hypersensitivity to bilastine or to any of the excipients .

Key safety warnings

The incidence of adverse events in patients with allergic rhinoconjunctivitis or chronic idiopathic urticaria treated with ALLERTINE was comparable with placebo at 12.7% versus 12.8%, with headache, somnolence and abdominal pain most commonly reported at frequencies comparable to placebo . Palpitations, tachycardia, hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, rash, localised oedema and erythema) and vomiting have been observed during post-marketing surveillance . The CNS safety profile and incidence of somnolence at the recommended dose were similar to placebo in clinical trials, and higher doses of bilastine up to 40 mg once daily did not affect psychomotor performance or driving performance .

Regulatory history

ALLERTINE bilastine 20 mg tablets were first listed on the Australian Register of Therapeutic Goods on 27 April 2022 . ALLERTINE MELTLETS bilastine 20 mg orally disintegrating tablets were subsequently listed on 26 February 2025 .